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510(k) K961084

AM 400 by Electone, Inc. — Product Code ESD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1996
Date Received
March 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Air-Conduction, Prescription
Device Class
Class I
Regulation Number
874.3300
Review Panel
EN
Submission Type

An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.

Other clearances by Electone, Inc.

  • K973266 — Z DEQ-II (September 23, 1997)
  • K955702 — SONATA U-01 (February 22, 1996)
  • K953050 — Z33 (August 22, 1995)
  • K953047 — Z20 (August 22, 1995)
  • K953054 — AM 260 OHM (August 15, 1995)
  • K953053 — AM 260 PP (August 15, 1995)
  • K953048 — Z22 (August 15, 1995)
  • K953049 — Z24 (August 15, 1995)
  • K953052 — AM 260 K-AMP (August 15, 1995)
  • K953051 — Z35 (August 15, 1995)

Other clearances for product code ESD

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  • K130790 — LYRIC2 (June 27, 2013)
  • K081136 — LYRIC HEARING AID (May 8, 2008)
  • K021867 — INSOUND XT SERIES HEARING AID (November 19, 2002)
  • K003558 — TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) (April 24, 2001)
  • K984518 — SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL (March 12, 1999)
  • K974751 — TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (March 6, 1998)
  • K974242 — ARGOSY PROGRAMMABLE ONQUE (January 20, 1998)
  • K973880 — SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM (January 12, 1998)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)